Claims Database Research Articles

Virginia Memory Project: Using the Healthy Brain Initiative Roadmap to design a statewide dementia registry

AbstractINTRODUCTIONThe Virginia Memory Project (VMP) is a statewide epidemiological registry for Alzheimer's disease and related disorders (ADRD) and other neurodegenerative conditions. It aims to support dementia research, policy, and care by leveraging the Centers for Disease Control (CDC) Healthy Brain Initiative (HBI) Roadmap.METHODSTo capture comprehensive data, the VMP integrates self‐enrollment and automatic enrollment using Virginia's All‐Payer Claims Database (APCD). It also adapts Behavioral Risk Factors Surveillance Survey (BRFSS) modules for self‐reported cognitive and caregiving data, offering connections to research, clinical services, and education.RESULTSVirginia successfully codified the VMP in the 2024 general assembly session.DISCUSSIONThe VMP demonstrates a novel approach to Alzheimer's Disease and Related Disorders (ADRD) surveillance by combining traditional registry functions with community engagement and workforce development. Future efforts will focus on increasing enrollment, especially among underrepresented groups, to enhance data‐driven dementia policy and care in Virginia.Highlights Integrated the Healthy Brain Initiative (HBI) domains into the newest statewide epidemiological dementia registry in the Commonwealth of Virginia. Collected data and identified gaps in the current research related to dementia and Alzheimer's related diseases. Aimed to mitigate barriers to dementia registry enrollment by identifying significant underdiagnosis and underrepresentation of racial and ethnic minority groups. Developed solutions to alleviate the current data and enrollment disparities and to connect individuals to research, physicians, and community groups.

Long-Term Revision-Free Survival Following Operative Fixation of Femoral Neck Fractures in Young Adults

OBJECTIVES: To identify the rate of fixation failure following femoral neck fracture (FNF) fixation in young adults within a national database. METHODS: Design: Retrospective cohort study Setting: National all-payer claims database Patient Selection Criteria: Adults between 18 and 49 years of age who underwent operative fixation for FNF (AO/OTA 31-B) between January 2010 and April 2019 were identified. Outcome Measures and Comparisons: The primary outcome measure was five-year risk of revision surgery for fixation failure following operative management of FNF. Additional data variables included rate of fixation failure following open versus closed reduction techniques and the rate of revision fixation, intertrochanteric osteotomy for nonunion or malunion, and conversion to arthroplasty. RESULTS: A total of 3,534 young adults underwent operative fixation of a FNF during the study period. The mean age of the study population was 41.1 +/- 3.91 years (18-49) and a majority were male (52.6%). The five-year revision-free survival of young adults who underwent operative fixation for FNF was 86.1% (95% CI 85.5-89.1%). Four-hundred ninety-two patients (13.9%) required revision surgical intervention for fixation failure, including 210 (5.9%) revision fixation procedures and 21 (0.6%) intertrochanteric osteotomies; two hundred sixty-one (7.4%) patients underwent conversion to arthroplasty. There was no significant difference in rate of fixation failure when comparing open (n=392, 14.9%) and closed (n=100, 13.3%) reduction techniques (p=0.351). CONCLUSIONS: Following operative management of FNF in young adults, fixation failure due to avascular necrosis, nonunion/malunion, or posttraumatic arthritis occurred at a rate of 13.9%. There was no difference in the rate of treatment failure between open and closed reduction. LEVEL OF EVIDENCE: Therapeutic Level IV

Treatment of patients with tumor/treatment-related hypothalamic obesity in the first two years following surgical treatment or radiotherapy

Survivors of sellar/suprasellar tumors involving hypothalamic structures face a risk of impaired quality of life, including tumor- and/or treatment-related hypothalamic obesity (TTR-HO) defined as abnormal weight gain resulting in severe persistent obesity due to physical, tumor- and/or treatment related damage of the hypothalamus. We analyze German claims data to better understand treatment pathways for patients living TTR-HO during the two years following the index surgical treatment. A database algorithm identified patients with TTR-HO in a representative German payer claims database between 2010 and 2021 (n = 5.42 million patients). Claims from 37 patients with TTR-HO were analyzed on a quarterly basis over 2 years. The analysis considered inpatient, outpatient, and prescription data. In the follow-up period, patients with TTR-HO are hospitalized 3.68 times on average; 37% of hospitalizations in year 1 and 31% in year 2 are due to TTR-HO. On average, patients see a general practitioner 12.27 times and various specialists 20.45 times. The need for complex neuroendocrine therapy develops quickly, with most patients having 2–3 neuroendocrine prescriptions in any given quarter. The management of patients with TTR-HO requires frequent inpatient and outpatient visits for tumor follow-up and management of incident comorbidities, and most patients with TTR-HO require intense polytherapy.

Association of changes in the type 2 diabetes and MASLD/related SLD status with risk of developing cardiovascular disease.

This study assessed the association of remission of type 2 diabetes mellitus (DM) or metabolic dysfunction-associated steatotic liver disease (MASLD)/related SLD (r-SLD; MASLD with excessive alcohol intake) as defined by the fatty liver index with the risk of cardiovascular disease (CVD). Health examination data at baseline and after 2 years (2-Years) were extracted from a nationwide claims database in Japan. Among participants aged 18-72 years with at least 3 years of follow-up, 9345 participants with DM-associated MASLD/r-SLD and 71 932 participants with non-DM MASLD/r-SLD at baseline were included in the study. The participants were stratified by the achievement of remission of MASLD/r-SLD or DM at 2-Years. In each group after stratification, the risk of new-onset CVD during the observation period was analysed using multivariate Cox proportional hazards models. During a median follow-up of 4.9 years (starting from 2-Years), 1368 cases of CVD were observed. The hazard ratio (95% confidence interval) for CVD was 0.50 (0.31-0.80) for participants with remission of DM, 0.65 (0.47-0.91) for participants with remission of MASLD/r-SLD, and 0.34 (0.15-0.77) for participants with remission of both DM and MASLD/r-SLD. Conversely, remission of MASLD/r-SLD was not linked to a reduced risk of CVD in participants with non-DM MASLD/r-SLD. The association of MASLD/r-SLD remission with CVD risk differs greatly in the presence and absence of DM. In patients with DM-MASLD/r-SLD, MASLD/r-SLD remission can significantly reduce CVD risk similarly as remission of DM.

Acne Relapse and Isotretinoin Retrial in Patients With Acne.

Isotretinoin is the only medical acne treatment capable of inducing acne remission; however, some patients experience acne relapse and require retrials of isotretinoin. There is a need to understand who is most at risk and how daily dose and cumulative dosage can influence outcomes. To assess rates of acne relapse and isotretinoin retrial and to identify associated factors among patients with acne who received an isotretinoin treatment course. This cohort study used data from the MarketScan commercial claims database from January 1, 2017, to December 31, 2020, to identify patients with acne who were 12 years or older and had received isotretinoin for 4 months or longer, with at least 1 year of continuous enrollment after completion of isotretinoin. Data analyses were performed from June 30, 2024, to August 1, 2024. Multivariable Cox proportional hazards regression was used to quantify associations of patient demographic and treatment characteristics with acne relapse and isotretinoin retrial. A total of 19 907 patients (mean [SD] age, 20.6 [7.8] years; 10 504 females [52.8%]) were included, among whom 4482 (22.5%) had acne relapse and 1639 (8.2%) had isotretinoin retrial. Female sex (hazard ratio [HR], 1.43; 95% CI, 1.35-1.52) was significantly associated with increased rates of acne relapse, and isotretinoin cumulative dosage (mg/kg) was associated with a decreased rate of acne relapse (HR, 0.996; 95% CI, 0.995-0.997). Furthermore, daily dose was not associated with decreased risk of acne relapse or isotretinoin retrial among those with conventional and high cumulative dosages. Female sex (HR, 0.68; 95% CI, 0.62-0.76) and isotretinoin cumulative dosage (HR, 0.99; 95% CI, 0.98-0.99) were associated with decreased rates of isotretinoin retrial. Stratification by cumulative dosage indicated that higher cumulative dosage was associated with decreased rates of retrial among patients with low (<120 mg/kg) and conventional (120-220 mg/kg), but not high (>220 mg/kg) cumulative dosage. Maximum daily dose (mg/kg/d) was not negatively associated with acne relapse or isotretinoin retrial in patients with cumulative dosage of 120 mg/kg or more. The findings of this cohort study suggest that higher cumulative dosage may potentially reduce risk of acne relapse and isotretinoin retrial. Furthermore, daily dose was not associated with decreased risk of the outcomes for conventional and high cumulative dosage; therefore, daily dosing could be individualized to patient goals and preferences.

Risk of insulin initiation with sodium-glucose cotransporter-2 inhibitors versus dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes mellitus: A real-world claims database study in Japan.

Insulin therapy is a cornerstone in type 2 diabetes mellitus (T2DM) management, but its use is associated with several barriers, including hypoglycaemia, fear of injections and high costs. We compared the risk of insulin initiation and other treatment intensification between patients with T2DM newly treated with a sodium-glucose cotransporter-2 inhibitor (SGLT2i) versus those newly treated with a dipeptidyl peptidase-4 inhibitor (DPP4i). This Japanese retrospective cohort study was conducted between 1 January 2015 and 31 March 2023 using the JMDC Claims Database. Patients with T2DM newly treated with an SGLT2i or a DPP4i were matched 1:1 using propensity score (n = 18 488 each). Incidence rates (IR) of insulin initiation, other antidiabetic drugs (OAD) and antihypertensive drugs added onto baseline treatment were calculated for each treatment group. Hazard ratios (HR) and 95% confidence intervals (CI) were calculated using a Cox proportional hazards model. The IR of insulin initiation was 0.95 and 2.12 per 1000 person-years in the SGLT2i and DPP4i groups, respectively, with significantly lower risk in the SGLT2i group than in the DPP4i group (HR 0.46, 95% CI: 0.28-0.74, p = 0.001). The risks of OAD (HR 0.66, 95% CI: 0.64-0.69, p < 0.001) and antihypertensive drugs (HR 0.90, 95% CI: 0.85-0.95, p < 0.001) added onto baseline treatment were lower in the SGLT2i group than in the DPP4i group. The risk of insulin initiation was lower in patients with T2DM newly treated with an SGLT2i than in those newly treated with a DPP4i. SGLT2i may reduce or delay the need for insulin therapy.

Factors Associated with the Timing of Initial Visit to Healthcare Providers for Injured Workers with Low Back Pain Claims: A Multijurisdiction Retrospective Cohort.

Evidence shows that patient outcomes following musculoskeletal injury have been associated with the timing of care. Despite the increasing number of injured workers presenting with low back pain (LBP) in primary care, little is known about the factors that are associated with the timing of initial healthcare provider visits. This study investigated factors that are associated with the timing of initial workers' compensation (WC)-funded care provider visits for LBP claims. We used a retrospective cohort design. A standardised multi-jurisdiction database of LBP claims with injury dates from July 2011 to June 2015 was analysed. Determinants of the time to initial general practitioner (GPs) and or musculoskeletal (MSK) therapists were investigated using an accelerated failure time model, with a time ratio (TR) > 1 indicating a longer time to initial healthcare provider visit. 9088 LBP claims were included. The median time to first healthcare provider visit was 3days (interquartile range (IQR) 1-9). Compared to General practitioners (GPs) (median 3days, IQR 1-8), the timing of initial consultation was longer if the first healthcare providers were MSK therapists (median 5days, IQR 2-14) (p < 0.001). Female workers had a shorter time to first healthcare provider visit [TR = 0.87; 95% CI (0.78, 0.97)] compared to males. It took twice as long to see MSK therapists first as it did to see GPs for injured workers [TR = 2.12; 95% CI (1.88, 2.40)]. Professional workers and those from remote areas also experienced delayed initial healthcare provider visits. The time to initial healthcare provider visit for compensable LBP varied significantly by certain occupational and contextual factors. Further research is needed to investigate the impact of the timing of initial visits to healthcare providers on claim outcomes.

Insurance gaps at age-19 and age-26 health insurance eligibility thresholds by childhood-onset condition severity, Colorado 2014-2018.

To characterize health insurance gap patterns related to age-19 Medicaid and age-26 commercial age-eligibility cutoffs. This descriptive analysis spans 2014-2018, after Affordable Care Act implementation, but before COVID-19 emergency provisions. We defined insurance gaps as ≥3 consecutive months without observed enrollment, preceded and followed by ≥1 month of enrollment and stratified results by insurance source and clinical severity (e.g., with chronic, complex, or disabling conditions or not). The Colorado all-payer claims database provided data for enrollees aged 10-29, 52% (649,346) of whom were initially Medicaid insured, whereas 47% (576,596) were commercially insured. The percent of enrollees with insurance gaps peaks within six months of turning age-19 and age-26-at 8.9% Medicaid and 8.7% commercial, respectively. The percentage point difference between ages 27-28 and 11-18 was 3.3 percentage points higher for prior Medicaid recipients (p < 0.001) and 2.2 percentage points greater for prior commercial enrollees (p < 0.001). Relative to the other clinical severity groups, young adults with disabling health conditions who were initially Medicaid insured had the lowest peak gap rate, 5.7%, compared with 10.5% among the previously commercially insured; this latter finding was sensitive to gap specification. Young adults would likely benefit from greater attention to age-19 and age-26 health insurance "unwinding."

Inpatient Hospitalizations for COVID-19 Among Patients With Prader-Willi Syndrome: A National Inpatient Sample Analysis.

Prader-Willi syndrome (PWS) is a genetic disorder associated with baseline respiratory impairment caused by multiple contributing etiologies. While this may be expected to increase the risk of severe COVID-19 infections in PWS patients, survey studies have suggested paradoxically low disease severity. To better characterize the course of COVID-19 infection in patients with PWS, this study analyses the outcomes of hospitalizations for COVID-19 among patients with and without PWS. The National Inpatient Sample, an all-payors administrative claims database of hospitalizations in the United States, was queried for patients with a coded diagnosis COVID-19 in 2020 and 2021. Hospitalizations for patients with PWS compared to those for patients without PWS using Augmented Inverse Propensity Weighting (AIPW). There were 295 (95% CI: 228-362) COVID-19 hospitalizations for individuals with PWS and 4,112,400 (95% CI: 4,051,497-4,173,303) for individuals without PWS. PWS patients had a median age of 33 years compared to 63 for those without PWS. Individuals with PWS had higher baseline rates of obesity (47.5% vs. 28.4%). AIPW models show that PWS diagnosis is associated with increased hospital length of stay by 7.43 days, hospital charges by $80,126, and the odds of mechanical ventilation and in-hospital death (odds ratios of 1.79 and 1.67, respectively). PWS patients hospitalized with COVID-19 experienced longer hospital stays, higher charges, and increased risk of mechanical ventilation and death. These results suggest that PWS should be considered a risk factor for severe COVID-19, warranting continued protective measures and vaccination efforts. Further research is needed to validate coding for PWS and assess the impact of evolving COVID-19 variants and population immunity on this vulnerable population.

Inclination of antidepressant medication continuation during pregnancy between 2012 and 2023 in Japan: A cohort study.

As multiple Japanese academic societies have recently issued treatment guidelines for perinatal antidepressant treatments, it is considered worthwhile to evaluate the latest trends and continuation of antidepressant medication during pregnancy to optimize antenatal prescriptions. The prevalence, trend, and continuation of antidepressant use during pregnancy in Japan from 2012 to 2023 were evaluated, using a large administrative claims database, in women whose pregnancies ended in live births. Annual changes were evaluated using a multivariate logistic regression model adjusted for maternal age at delivery. Of 179,797 women with a mean maternal age at delivery of 32.5 years, 1870 (1.04 %) were prescribed antidepressants during pregnancy. The prevalence significantly increased (P < 0.0001) from 0.63 % in 2012 to 1.67 % in 2023. Antidepressants were prescribed to 1730 women (0.96 %) during the first trimester. Of these, 670 (38.7 %) were antidepressant continuers throughout pregnancy, showing a significant increase (P < 0.0001) from 19.51 % in 2012 to 50.70 % in 2023. The most frequently prescribed class of antidepressants during pregnancy was serotonin reuptake inhibitors (0.74 %), especially sertraline (0.33 %) and escitalopram (0.23 %), with a significant increase in their annual prevalence. Prescriptions for women whose pregnancies ended in abortion or stillbirth could not be evaluated. Given that antidepressant use and its continuation during pregnancy have become more common, it is important to further disseminate knowledge of the guidelines to healthcare professionals and women of childbearing age, including the promotion of preconception care and shared decision-making.

Health Care Resource Use and Costs of Rivaroxaban Versus Warfarin Among Nonvalvular Atrial Fibrillation Polypharmacy Patients With Obesity.

The economic burden of nonvalvular atrial fibrillation (NVAF) is substantial. Many patients with NVAF are obese and manage other health conditions requiring multiple medications. This real-world study compared health care resource use (HRU) and costs for rivaroxaban and warfarin in patients with NVAF who had polypharmacy and obesity. We used health care claims databases (Merative MarketScan commercial and Medicare supplemental claims) to identify patients initiating the direct oral anticoagulant rivaroxaban or warfarin with ≥1 diagnostic claim for atrial fibrillation, presence of polypharmacy (based on 3 categories for the number of concurrent medications: 1-4, 5-9, ≥10), and obesity. Cohorts were balanced for demographic and baseline characteristics using propensity score matching. All-cause and NVAF-related HRU rates and costs were compared between treatments using rate ratios and adjusted mean differences per patient per year. Eligible patients totaled 95 875, with 19 990 patients in each treatment cohort following propensity score matching. All-cause HRU rates were significantly lower with rivaroxaban versus warfarin, and hospital stays were reduced by 3.1 days with rivaroxaban. Mean (95% CI) all-cause total medical and total health care costs per patient per year were significantly reduced with rivaroxaban versus warfarin (-$4499 [-$5660 to -$3305] and -$1627 [-$2790 to -$438], respectively). NVAF-related HRU was reduced with rivaroxaban versus warfarin, but total NVAF-related medical costs were not significantly different between treatment groups ($144 [-$756 to $1079] per patient per year). Subgroup and sensitivity analysis results were generally consistent with the main analysis. Among patients with NVAF, polypharmacy, and obesity, rivaroxaban was associated with a reduction in HRU and all-cause costs compared with warfarin.

Birth Outcomes of Infants Born to Mothers with Alopecia Areata: A Nationwide Population-based Study in Korea.

Data on pregnancy outcomes in patients with alopecia areata (AA) are limited. The aim of this study is to determine the association between maternal AA and risk of adverse birth outcomes in children. A retrospective cohort study was conducted on 45,328 children born to mothers with AA and 4,703,253 controls born to mothers without AA using the Korean National Health Insurance Claims database from 2002 to 2016. Multivariate logistic regression analyses were performed to evaluate the association between maternal AA and the birth outcomes of their children. Infants born to mothers with AA exhibited a significantly higher risk of preterm birth (odds ratio [OR] 1.39, 95% CI 1.33-1.45; adjusted OR [aOR] 1.07, 95% CI 1.01-1.13), low birthweight (OR 1.36, 95% CI 1.30-1.42; aOR 1.11, 95% CI 1.05-1.17), and Caesarean section birth (OR 1.24, 95% CI 1.22-1.26; aOR 1.12, 95% CI 1.08-1.15) than controls. In addition, the risk of congenital malformations was also significantly higher in infants born to mothers with AA (OR 1.19, 95% CI 1.15-1.22; aOR 1.10, 95% CI 1.07-1.14), especially for malformations of the urinary (OR 1.33, 95% CI 1.19-1.48; aOR 1.16, 95% CI 1.04-1.29) and musculoskeletal (OR 1.19, 95% CI 1.12-1.27; aOR 1.12, 95% CI 1.05-1.19) systems, than controls. Maternal AA is associated with an increased risk of adverse birth outcomes in infants.

Prevalence of urinary tract infections in women with vulvovaginal atrophy and the impact of vaginal prasterone on the rate of urinary tract infections.

The aims of this study were to assess the prevalence of urinary tract infections (UTI) in women newly diagnosed with vulvovaginal atrophy (VVA) versus women without VVA and to evaluate the potential of vaginal prasterone to be used in postmenopausal VVA women with UTI as prophylaxis to reduce the future UTI risk. As a first subgroup analysis, women using aromatase inhibitors, medications that stop the production of estrogen were analyzed. As a second subgroup analysis, we looked at women with diabetes to investigate whether the same prophylaxis approach should be considered. This observational retrospective inception cohort study was conducted using the Integrated Dataverse open-source claims database with data from February 2015 through January 2020. A total of 22,245 women treated with prasterone for a minimum of 12 weeks were matched to women without any prescribed VVA-related treatment. Overall, women treated with prasterone have a significantly lower UTI prevalence compared to those untreated (6.58% vs 12.3%; P < 0.0001). The highest difference in UTI prevalence among the prasterone treated and untreated women was observed in those aged 65-74 (7.15% vs 16.2%; P < 0.0001). Among aromatase inhibitor users and women with diabetes, those treated with prasterone have a significantly lower UTI prevalence (4.90% vs 9.79%; P < 0.01 and 14.59% vs 20.48%; P < 0.0001, respectively). This study suggests that intravaginal prasterone may be a good candidate for prophylaxis in postmenopausal women with UTI to reduce future UTI risk, including for women taking aromatase inhibitors and women with diabetes. This study is based on real-world evidence and warrants further investigation in a clinical setting.

High-Cost Cancer Drug Use in Medicare Advantage and Traditional Medicare

Medicare Advantage (MA) plans are designed to incentivize the use of less expensive drugs through capitated payments, formulary control, and preauthorizations for certain drugs. These conditions may reduce spending on high-cost therapies for conditions such as cancer, a condition that is among the most expensive to treat. To determine whether patients insured by MA plans receive less high-cost drugs than those insured by traditional Medicare (TM). This cohort study used data from the linked Colorado All Payer Claims Database and Colorado Central Cancer Registry. This population-based cohort included adults 65 years and older insured by Medicare with prescription coverage who reside in Colorado and were diagnosed with colorectal (CRC) or non-small cell lung cancer (NSCLC) between January 2012 and December 2021. The data were analyzed between December 2023 and August 2024. Enrollment in TM or MA insurance plans. Claims for chemotherapy and oral targeted agents were identified. Thresholds for high-cost drugs were based on the distribution of drug costs. Inverse probability weighted logistic regression for receiving any cancer drug and for receiving a high-cost cancer drug was estimated, controlling for patient and ecological characteristics. The sample was stratified by cancer site and local/regional and distant stage. Of 4240 patients included in the analysis (mean [SD] age, 75 [7] years; 2327 [54.9%] female), 1991 were diagnosed with CRC and 2249 with NSCLC. A total of 1647 patients had local or regional CRC, and 344 had distant CRC; 1351 patients had local or regional NSCLC, and 898 had distant NSCLC. In the covariate-adjusted analysis, patients diagnosed with local or regional CRC who were insured by MA were 6.0 percentage points less likely to receive a cancer drug than similar patients insured by TM. Patients diagnosed with distant NSCLC were 10.0 percentage points less likely to receive a cancer drug if insured by MA. Among patients who received a cancer drug, patients insured by MA were less likely to receive a high-cost drug for local or regional CRC (by 10.0 percentage points) and distant CRC (by 9.0 percentage points). In this cohort study, high-cost drugs were more commonly prescribed among patients enrolled in TM and diagnosed with CRC. A similar pattern was not observed for patients with NSCLC, perhaps because clinical evidence suggests survival benefits to be associated only with certain drugs, all of which are expensive. Nonetheless, MA was modestly associated with reduced high-cost drug utilization and may reduce overall treatment costs.

Persistence of advanced therapies in patients with inflammatory bowel disease: retrospective cohort study using a large healthcare claims database in Japan.

There are few studies that comprehensively report real-world persistence for first-line advanced therapies used to treat inflammatory bowel disease. We aimed to describe persistence of first-line advanced therapies among incident biologic or Janus kinase inhibitor users with inflammatory bowel disease. Retrospective cohort study using the Japan Medical Data Center database from January 1, 2010, until September 30, 2022. Patients aged ≥15 years with relevant diagnostic and treatment codes were included. All eligible patients were observed until study end (September 30, 2022), death, or disenrollment, whichever occurred first. Among 1,115 patients with Crohn's disease included in the analysis, 41.4% initiated adalimumab, 37.4% infliximab, 18.1% ustekinumab, and 3.0% vedolizumab. Median age was 31.2-34.8 years, 72.8% to 85.9% were male. Persistence at 12 months was 84.7% for adalimumab, 87.7% for infliximab, 91.3% for ustekinumab, and 53.1% for vedolizumab. Persistence at 24 months was 76.3%, 76.8%, 80.4%, and 28.6%, respectively. Among 1,942 patients with ulcerative colitis, 24.8% initiated adalimumab, 33.6% infliximab, 11.2% golimumab, 17.5% vedolizumab, 5.6% ustekinumab, and 7.3% tofacitinib. Mean age was 38.2-40.4 years, 57.4% to 65.8% were male. Persistence at 12 months was 57.6% for adalimumab, 87.7% for infliximab, 54.9% for golimumab, 69.7% for vedolizumab, and 84.0% for ustekinumab. At month 24, persistence for ustekinumab was 75.0%, versus 42.9%-59.4% for other treatments. Index treatment with ustekinumab resulted in high persistence through 24 months after initiation in patients with Crohn's disease or ulcerative colitis. Our study provides insights into the real-world usage of advanced treatments for patients with IBD in Japan.

Incidence of Severe Illness in Pediatric Influenza Outpatients Treated with Baloxavir or Neuraminidase Inhibitors.

A single oral dose of baloxavir marboxil, a cap-dependent endonuclease inhibitor, is approved for patients with influenza A or B infection; however, real-world evidence is limited. We evaluated the effectiveness of baloxavir vs neuraminidase inhibitors in reducing the incidence of severe illness in influenza outpatients aged 5-11 years. In this retrospective cohort study, we analyzed individual-level data from patients treated with these antivirals, using a large, Japanese health insurance claims database (JMDC). Patients were included at the first date of diagnosis of the influenza virus infection (Day 1) in two influenza seasons. The primary outcome was the incidence of hospitalization from Day 2-14. Of 196,749 included patients (Season 2018/2019, n=103,709; Season 2019/2020, n=93,040), 20.9% received baloxavir, 38.8% received oseltamivir, 28.7% received laninamivir, and 11.6% received zanamivir. In each treatment group, 61-70% patients had influenza A. The incidence of hospitalization from Day 2-14 was significantly lower for baloxavir than for oseltamivir, laninamivir, and zanamivir. The adjusted risk ratio (95% CI) for oseltamivir, laninamivir, and zanamivir were 1.86 (1.30-2.68), 2.11 (1.37-3.25), and 1.90 (1.31-2.77), respectively, compared with baloxavir. Comparative incidence of hospitalizations between agents were unaffected by season or virus type. Using a large, Japanese health insurance claims database, a lower rate of hospitalization was demonstrated in children aged 5-11 years with an influenza virus infection when treated with baloxavir vs neuraminidase inhibitors. Thus, single dose, oral baloxavir may reduce the incidence of severe illness in these patients.

Riluzole is associated with reduced risk of heart failure.

Reduction of intracellular Na+ accumulation through late Na+ current inhibition has been recognized as a target for cardiac Ca2+ handling which underlies myocardial contractility and relaxation in heart failure (HF). Riluzole, an Na+ channel blocker with enhancement of Ca2+-activated K+ channel function, used for management of amyotrophic lateral sclerosis (ALS), is effective in suppressing Ca2+ leak and therefore may improve cardiac function. The study aim was to investigate whether riluzole lowers HF incidence. Rates of HF incident were compared using a commercial insurance and Medicare supplement claims databases. Patients with a filled riluzole prescription (treatment) between 06/2009 and 12/2019 were compared to those with no-riluzole (control). We excluded HF patients during the 180-day baseline period. Study endpoint was the first HF diagnosis from the index riluzole prescription or ALS diagnosis. HF onset was compared between the propensity score matched treatment and control cohorts. The matched cohort consisted of 4060 pairs of riluzole/control patients. The 24-month cumulative incidence of HF onset for riluzole versus control patients was 4.96% versus 7.27%, calculating hazard ratio (HR) [95% CI, p-value] of 0.55 [0.40-0.76, p < 0.01]. The HR estimates favoring riluzole over the ALS control were consistent across the 3 months to 2-year follow-up. The clinically and statistically significant effect on HF onset was driven by the lower rate of HFrEF with the 2-year HR [95% CI] of 0.46 [0.21-0.99]. Riluzole is associated with a lower rate of HF onset, suggesting a potential prevention strategy for early management.

Risk Factors and Prognostic Effects of Aspergillosis as a Complication of Nontuberculous Mycobacterial Pulmonary Disease: A Nested Case-Control Study.

The global prevalence of nontuberculous mycobacterial pulmonary disease (NTM-PD) has been steadily increasing. A few small retrospective studies have reported a poor prognosis associated with chronic pulmonary aspergillosis (CPA) as a complication of NTM-PD. Furthermore, the prognostic impact of CPA may have been inadequately assessed due to differences in background factors. This study aimed to identify the risk factors for CPA in NTM-PD and compare the risk of in-hospital mortality between patients with and without aspergillosis. Data were obtained from a large-scale claims database. Patients with NTM-PD who met the inclusion criteria and those who developed CPA after the NTM diagnosis were identified. The incidence of CPA was evaluated, and risk factors were identified using multiple logistic analyses. Mortality rates were evaluated and compared between patients with and without aspergillosis after adjusting for background CPA risk factors. The incidence of CPA was 2.29% (265/11,587). The identified risk factors included male sex, chronic respiratory failure, asthma, interstitial pneumonia, pulmonary tuberculosis sequelae and systemic corticosteroid use. A total of 219 patients with CPA were matched with control cases using propensity scores based on age and identified risk factors for CPA. The adjusted hazard ratio for in-hospital mortality was 2.6 (95% CI: 1.8-3.9). CPA as a complication of NTM-PD is associated with significantly higher mortality rates. Clinicians should consider the necessity of promptly diagnosing CPA in patients with NTM-PD and the associated risk factors.

Risk of atrial fibrillation in women treated for breast cancer: Observational study from the French National Health Insurance Claims Database

Risk of atrial fibrillation in women treated for breast cancer: Observational study from the French National Health Insurance Claims Database

Investigating the Applicability of an Administrative Claims Database in Japan in Collecting Safety Information on Diseases for Which Patients Visit Multiple Facilities during Drug Treatment

Investigating the Applicability of an Administrative Claims Database in Japan in Collecting Safety Information on Diseases for Which Patients Visit Multiple Facilities during Drug Treatment